CA2544432C - Composition pharmaceutique stable comportant le facteur stimulant les colonies de granulocytes - Google Patents
Composition pharmaceutique stable comportant le facteur stimulant les colonies de granulocytes Download PDFInfo
- Publication number
- CA2544432C CA2544432C CA2544432A CA2544432A CA2544432C CA 2544432 C CA2544432 C CA 2544432C CA 2544432 A CA2544432 A CA 2544432A CA 2544432 A CA2544432 A CA 2544432A CA 2544432 C CA2544432 C CA 2544432C
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- Prior art keywords
- csf
- composition
- acid
- acetic acid
- sorbitol
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- HQPMKSGTIOYHJT-UHFFFAOYSA-N ethane-1,2-diol;propane-1,2-diol Chemical compound OCCO.CC(O)CO HQPMKSGTIOYHJT-UHFFFAOYSA-N 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
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- 238000007710 freezing Methods 0.000 description 1
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- DLRVVLDZNNYCBX-CQUJWQHSSA-N gentiobiose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-CQUJWQHSSA-N 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
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- 150000002337 glycosamines Chemical class 0.000 description 1
- 230000013595 glycosylation Effects 0.000 description 1
- 238000006206 glycosylation reaction Methods 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
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- 230000003301 hydrolyzing effect Effects 0.000 description 1
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- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 description 1
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- DLRVVLDZNNYCBX-RTPHMHGBSA-N isomaltose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-RTPHMHGBSA-N 0.000 description 1
- 229960002618 lenograstim Drugs 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
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- 238000011068 loading method Methods 0.000 description 1
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- 229930182817 methionine Natural products 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
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- 239000003002 pH adjusting agent Substances 0.000 description 1
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- 150000002978 peroxides Chemical class 0.000 description 1
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- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
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- 238000001959 radiotherapy Methods 0.000 description 1
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- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- ALZJERAWTOKHNO-UHFFFAOYSA-M sodium;dodecyl sulfate;3-morpholin-4-ylpropane-1-sulfonic acid Chemical compound [Na+].OS(=O)(=O)CCCN1CCOCC1.CCCCCCCCCCCCOS([O-])(=O)=O ALZJERAWTOKHNO-UHFFFAOYSA-M 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
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- WROMPOXWARCANT-UHFFFAOYSA-N tfa trifluoroacetic acid Chemical compound OC(=O)C(F)(F)F.OC(=O)C(F)(F)F WROMPOXWARCANT-UHFFFAOYSA-N 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 230000001732 thrombotic effect Effects 0.000 description 1
- 239000013638 trimer Substances 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/193—Colony stimulating factors [CSF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/53—Colony-stimulating factor [CSF]
- C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
Nouvelle composition pharmaceutique stable contenant le facteur stimulant les colonies de granulocytes (G-CSF).
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2003/005575 WO2005042024A1 (fr) | 2003-11-04 | 2003-11-04 | Composition pharmaceutique stable comportant le facteur stimulant les colonies de granulocytes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2544432A1 CA2544432A1 (fr) | 2005-05-12 |
| CA2544432C true CA2544432C (fr) | 2011-06-28 |
Family
ID=34531842
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2544432A Expired - Fee Related CA2544432C (fr) | 2003-11-04 | 2003-11-04 | Composition pharmaceutique stable comportant le facteur stimulant les colonies de granulocytes |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US7585496B2 (fr) |
| EP (1) | EP1682184B1 (fr) |
| JP (1) | JP5129927B2 (fr) |
| CN (1) | CN1878570B (fr) |
| AU (1) | AU2003283664B2 (fr) |
| CA (1) | CA2544432C (fr) |
| SI (1) | SI1682184T1 (fr) |
| WO (1) | WO2005042024A1 (fr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW200722521A (en) * | 2005-06-01 | 2007-06-16 | Alza Corp | Novel bioconjugation reactions for acylating polyethylene glycol reagents |
| DE202006020194U1 (de) | 2006-03-01 | 2007-12-06 | Bioceuticals Arzneimittel Ag | G-CSF-Flüssigformulierung |
| PL2142174T3 (pl) * | 2007-04-05 | 2011-08-31 | Sandoz Ag | Stabilne wodne preparaty G-CSF |
| MX2010002348A (es) | 2007-08-27 | 2010-07-30 | Biogenerix Ag | Formulacion liquida de g-csf. |
| MX2010002448A (es) | 2007-08-27 | 2010-10-04 | Biogenerix Ag | Formulacion liquida del g-csf conjugado. |
| DE102007040932A1 (de) | 2007-08-27 | 2009-03-05 | Biogenerix Ag | Flüssigformulierung von G-CSF |
| JP2011001273A (ja) * | 2009-06-16 | 2011-01-06 | Eci Inc | ｅＭＩＰを有効成分とする水溶性製剤 |
| WO2011023572A1 (fr) | 2009-08-25 | 2011-03-03 | Basf Se | Procédé de production de particules polymériques absorbant l'eau à absorption du sang améliorée par polymérisation de gouttes d'une solution de monomère |
| EP2399572A1 (fr) | 2010-06-22 | 2011-12-28 | Sandoz AG | Stockage à long terme de G-CSF humain recombinant non glycosylé |
| TWI480288B (zh) | 2010-09-23 | 2015-04-11 | Lilly Co Eli | 牛顆粒細胞群落刺激因子及其變體之調配物 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4252069A (en) * | 1979-04-13 | 1981-02-24 | Combustion Engineering, Inc. | Low load coal bucket |
| JP3507486B2 (ja) * | 1991-03-15 | 2004-03-15 | アムジエン・インコーポレーテツド | 顆粒球コロニー刺激因子の肺内投与 |
| DE4242919A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF |
| WO1999044630A1 (fr) * | 1998-03-06 | 1999-09-10 | Chugai Seiyaku Kabushiki Kaisha | Preparations exemptes de proteines |
| US6432449B1 (en) * | 1998-05-18 | 2002-08-13 | Amgen Inc. | Biodegradable sustained-release alginate gels |
| ATE260674T1 (de) * | 1998-08-17 | 2004-03-15 | Pfizer Prod Inc | Stabilisierte proteinzusammensetzung |
| US6245740B1 (en) * | 1998-12-23 | 2001-06-12 | Amgen Inc. | Polyol:oil suspensions for the sustained release of proteins |
| EP1129720B1 (fr) | 2000-02-29 | 2004-06-23 | Pfizer Products Inc. | Composition stabilisée d'un facteur stimulant les colonies de granulocytes |
| AU2002213441B2 (en) * | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US6579521B2 (en) * | 2000-10-20 | 2003-06-17 | Chiron Corporation | Methods of therapy for HIV infection |
| US6439136B1 (en) * | 2001-07-03 | 2002-08-27 | Alstom (Switzerland) Ltd | Pulverized solid fuel nozzle tip with ceramic component |
-
2003
- 2003-11-04 CN CN2003801106592A patent/CN1878570B/zh not_active Expired - Fee Related
- 2003-11-04 CA CA2544432A patent/CA2544432C/fr not_active Expired - Fee Related
- 2003-11-04 EP EP03775645.9A patent/EP1682184B1/fr not_active Expired - Lifetime
- 2003-11-04 SI SI200332332T patent/SI1682184T1/sl unknown
- 2003-11-04 AU AU2003283664A patent/AU2003283664B2/en not_active Ceased
- 2003-11-04 JP JP2005510116A patent/JP5129927B2/ja not_active Expired - Fee Related
- 2003-11-04 US US10/577,285 patent/US7585496B2/en not_active Expired - Fee Related
- 2003-11-04 WO PCT/IB2003/005575 patent/WO2005042024A1/fr not_active Ceased
-
2009
- 2009-09-04 US US12/554,304 patent/US8580246B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US20100021419A1 (en) | 2010-01-28 |
| US8580246B2 (en) | 2013-11-12 |
| WO2005042024A1 (fr) | 2005-05-12 |
| US20070081971A1 (en) | 2007-04-12 |
| AU2003283664B2 (en) | 2010-08-19 |
| EP1682184A1 (fr) | 2006-07-26 |
| EP1682184B1 (fr) | 2013-10-16 |
| JP5129927B2 (ja) | 2013-01-30 |
| JP2007527357A (ja) | 2007-09-27 |
| AU2003283664A1 (en) | 2005-05-19 |
| CN1878570B (zh) | 2010-10-06 |
| CN1878570A (zh) | 2006-12-13 |
| CA2544432A1 (fr) | 2005-05-12 |
| US7585496B2 (en) | 2009-09-08 |
| SI1682184T1 (sl) | 2014-02-28 |
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| JPWO2001064241A1 (ja) | 長期安定化製剤 | |
| AU2004305421B2 (en) | A pharmaceutical composition comprising an active principle and sulphobetaine | |
| US9387233B2 (en) | Long-term storage of non-glycosylated recombinant human G-CSF | |
| WO2007034509A2 (fr) | Formulation d'un facteur de stimulation de colonies de granulocytes de recombinaison et procede de preparation correspondant | |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20201104 |